Subpart E. Subpart E—Premarket Notification Procedures

• § 807.81 - When a premarket notification submission is required.
• § 807.85 - Exemption from premarket notification.
• § 807.87 - Information required in a premarket notification submission.
• § 807.90 - Format of a premarket notification submission.
• § 807.92 - Content and format of a 510(k) summary.
• § 807.93 - Content and format of a 510(k) statement.
• § 807.94 - Format of a class III certification.
• § 807.95 - Confidentiality of information.
• § 807.97 - Misbranding by reference to premarket notification.
• § 807.100 - FDA action on a premarket notification.